{"id":16898,"date":"2020-12-16T17:34:14","date_gmt":"2020-12-16T16:34:14","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=16898"},"modified":"2023-01-24T14:59:03","modified_gmt":"2023-01-24T13:59:03","slug":"usa-fda-issues-certificate-cdne","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/12\/16\/usa-fda-issues-certificate-cdne\/","title":{"rendered":"USA: FDA issues Certificate for Devices not Exported from U.S.A. (CDNE)"},"content":{"rendered":"\n

Last month,\nthe U.S. Food & Drug Administration (FDA)<\/strong> published online\ninformation on Certificate for Device Not Exported from the United States\n(CDNE)<\/strong>. This is a new form of certification designed for Medical Devices manufactured outside the\nUnited States<\/strong>, therefore not suitable for standard export certificates and\nshipped to a non-US country.<\/p>\n\n\n\n

The instructions for issuing the CDNE can be found in the amendments to\nsection 801 (e) (4) (E) (iii) of the Federal Food, Drug, and Cosmetic Act\n(FD&C Act).<\/p>\n\n\n\n

\"FDA
FDA issues Certificates for Devices not Exported from U.S.A. (CDNE)<\/figcaption><\/figure>\n\n\n\n

Requirements for obtaining a Certificate for Devices not Exported from U.S.A.<\/strong><\/h2>\n\n\n\n

A CDNE certificate may be issued for Medical Devices manufactured outside of the United States meeting the following requirements<\/strong>:<\/p>\n\n\n\n